Barry v. Medtronic, Inc.

• Decision Date: 24 March 2017
• Docket Number: CIVIL ACTION No. 1:14–cv–104
• Citation: 245 F.Supp.3d 793
• Parties: Mark BARRY, M.D., Plaintiff, v. MEDTRONIC, INC., Defendant.
• Court: U.S. District Court — Eastern District of Texas

245 F.Supp.3d 793

Mark BARRY, M.D., Plaintiff,

v.MEDTRONIC, INC., Defendant.

CIVIL ACTION No. 1:14–cv–104

United States District Court, E.D. Texas, Beaumont Division.

Signed March 24, 2017

Sean P. DeBruine, Dan Johnson Law Group, San Francisco, CA, Dario Alexander Machleidt, Kilpatrick Townsend & Stockton LLP, Seattle, WA, David Clay Holloway, Kilpatrick Townsend & Stockton LLP, Atlanta, GA, Erwin Lee Cena, Kilpatrick Stockton LLP, San Diego, CA, Laura Kathryn Mullendore, Kilpatrick Townsend & Stockton LLP, Denver, CO, for Plaintiff.

Julie P. Bookbinder, pro hac vice, Scott J. Bornstein, Cassandra A. Adams, John Edward Handy, Richard Charles Pettus, Zahra Alexis Smith, Allan A. Kassenoff, Greenberg Traurig, LLP, New York, NY, Aimee Marie Housinger, Mary–Olga Lovett, Greenberg Traurig LLP, Houston, TX, Clyde Moody Siebman, Siebman Burg Phillips & Smith LLP, Sherman, TX, Elizabeth Siebman Forrest, Siebman, Burg, Phillips & Smith LLP, Plano, TX, Eric Fletcher, Wilmer Cutler Pickering Hale & Dorr, Boston, MA, for Defendant.

FINDINGS AND CONCLUSIONS REGARDING INEQUITABLE CONDUCT

Ron Clark, United States District Judge

Plaintiff Dr. Mark A. Barry brought suit, asserting that Defendant Medtronic, Inc. indirectly infringed two patents,¹ U.S. Patent No. 7,670,358 ("the '358 Patent") and U.S. Patent No. 8,361,121 ("the '121 Patent"), which relate to a system and method of aligning spinal vertebrae to correct common spinal deformities like scoliosis. The issues of infringement, invalidity, willfulness, and damages were tried to a jury. The jury found that Medtronic indirectly infringed each of the asserted claims of the patents-in-suit, did not find any of the asserted claims to be invalid, and awarded damages. Dkt. 411 (Jury Verdict).

Following the jury trial, the court held a bench trial on Medtronic's claims of inequitable conduct,² which fall into two categories: (A) Dr. Barry made and failed to correct false statements and withheld material information regarding Figure 6 (a photograph of a set of x-rays) in the patents' specification; and (B) Dr. Barry failed to disclose to the PTO several categories of material prior art. There are four categories of prior art that were allegedly withheld: (a) Dr. Barry's own surgeries that took place prior to the critical date of December 30, 2004 ("pre-critical date surgeries"), (b) an abstract authored by Dr. Barry for an industry conference known as the IMAST conference ("the IMAST Abstract") (Dkt. 353–1 at 31), (c) Dr. Barry's pre-critical date interactions with medical device companies (Dkt. 353–1 at 34, 38), and (d) Dr. Lawrence Lenke's alleged prior invention (Dkt. 353–1 at 42).³

With regards to Figure 6, Medtronic also alleges that Dr. Barry's misconduct continued after issuance of the patents-in-suit, giving rise to a "continuing pattern of deceit," which is relevant to a finding of specific intent. Dkt. 353–1 at 42–49 (citing Intellect Wireless Inc. v. HTC Corp. , 732 F.3d 1339, 1344–45 (Fed. Cir. 2013) ). According to Medtronic, Dr. Barry's attempts to correct the specification, his more recent filing of continuation application No. 13/645,589 (an application related to the patents-in-suit), and his representations to the PTO during inter partes review of the '358 Patent demonstrate a continuing pattern of deceit. Dkt. 353–1 at 42–49.

Pursuant to Federal Rule of Civil Procedure 52(a)(1), the court now makes these findings and conclusions with respect to Medtronic's inequitable conduct allegations. In summary, Medtronic did not meet its burden of proving by clear and convincing evidence that the patents are unenforceable due to inequitable conduct under any of its theories. The court finds Medtronic did not show that Dr. Barry or his attorneys, with a specific intent to deceive the PTO made, or failed to correct, representations they knew at the time to be false or that they knowingly failed to disclose material prior art to the PTO.

Specifically, the court finds that Medtronic completely failed to sustain its burden of proof on specific intent. It is therefore not surprising that the court finds that Medtronic did not prove affirmative egregious misconduct, which would establish an exception to the requirement that materiality be separately proven. The court also finds that Medtronic did not establish materiality. The materiality prong of inequitable conduct analysis involves consideration of the evidence under the PTO's preponderance of the evidence standard, so that determination may be a closer call than the finding of no specific intent. Regardless, because there was no specific intent, Medtronic's inequitable conduct allegations must fail.

I. FACTUAL BACKGROUND⁴

Medtronic presents a smorgasbord of acts and omissions, each of which are claimed to constitute inequitable conduct. The first of these supposedly occurred during the drafting of the initial application in 2004; the most recent were allegedly committed during the 2015–2016 inter partes review proceedings. The following timeline is helpful in understanding this litany of complaints.

Relevant Prosecution History

December 30, 2004 : Dr. Barry and Mr. Henry filed the application that issued as the '358 Patent, application No. 11/027, 026. PX 1.

The involvement of patent attorney Mr. David Henry

? Dr. Barry's patent attorney at the time of prosecution was Dr. David Henry, an attorney at the law firm of Gray, Reed & McGraw.⁵

? Mr. Henry was first contacted by Dr. Barry regarding filing a patent in December 2004. Tr. at 2176:19–21.

? Mr. Henry assisted Dr. Barry in preparing and submitting that application to the PTO. (PX 4, File History). Mr. Henry signed the application and prepared Dr. Barry's patent. PX 004.005; see also Tr. at 270:8–271:5.

? Mr. Henry provided Dr. Barry with a questionnaire that was intended to "ferret" out issues of when something was invented, whether it was put into commercial or public use, described in printed publication, etc. Tr. at 2183:20–2184:15.

? A memo produced by Dr. Barry states, in part, that he has a duty to disclose prior art. As disclosed in the memo, that duty covers information regarding "sales, uses, or public disclosures of the invention or products similar to the invention." DX 105; Tr. at 2210 (Mr. Henry's testimony regarding DX 105); Tr. at 2237:23–2238:3 (Dr. Barry's testimony regarding DX 105).

January 23, 2008 : the PTO examiner issued a non–Final Office Action rejecting claims 1 through 10 on the basis that a number of figures, including Figure 6 (then labeled Figure 7),⁶ were "unclear" and did not "distinctly show features which are pertinent to the understanding of the disclosed device." The examiner required new "drawings." PX 004.075–PX 004.077 (Figure 7 and new Figure 6 are photos of three x-rays).

September 11, 2008 : in response to the non-final Office Action, Dr. Barry replaced the photos of the x-rays with a clearer image. PX 004.151. Between the notice and Dr. Barry's response, the application was considered abandoned and revived under 37 C.F.R. 1.137(b). PX 004.160 (letter dated December 17, 2008).

February 11, 2009 : the PTO issued a Final Office Action in which it rejected certain claims and once again objected to Figure 6, again stating that it "is unclear and does not distinctly show features which are pertinent to the understanding of the disclosed device." PX 004.163–PX 004.164.

July 13, 2009 : In response to the February 11th rejection, Dr. Barry amended Figure 6 (PX 004.181; PX 004.194) through a "Reply to Office Action," replacing the x-ray image, stating that the replacement was a "clearer image" and "no new matter has been introduced by the replacement drawing." PX 004.182.

October 1, 2009 : the PTO sent Dr. Barry a notice of allowance. PX 004.197.

March 2, 2010 : the '358 Patent issued. PX 1.

August 16, 2010 : the application that later issued as the '121 Patent, application No. 12/857,320, was filed as a continuation of application No. 11/202,409, which was filed on January 29, 2013, as a continuation in part of application No. 11/027, 026, which was the application that issued as the '358 Patent. PX 2.

January 29, 2013 : the '121 Patent issued. PX 2.

? The '358 and '121 Patents bear the same title, "System and Method for Aligning Vertebrae in the Ameliorating of Aberrant Spinal Column Deviation Conditions" and share an almost identical specification.⁷

? Both patents have a priority date of December 30, 2004, the day that the application which issued as the '358 Patent was filed. See JMOL Order (Dkt. 442), at 28–29.

Inter Partes Review of the '358 Patent ⁸

September 9, 2015 : the PTAB instituted review of claims 1–5 of the '358 Patent. Medtronic, Inc. v. Mark A. Barry , No. IPR2015–00780, 2015 WL 9899015 (P.T.A.B. Sept. 9, 2015) (Paper 7, Institution Decision).

September 7, 2016 : the PTAB in a Final Written Decision (Paper 51, Termination Decision Document) found that Medtronic had not demonstrated by a preponderance of the evidence that the challenged claims of the '358 Patent are unpatentable.

Figure 6 of the specification

? The patents' common specification contains a Figure 6, which is a photograph of a series of x-rays.

? At the time Dr. Barry filed his application for both patents-in-suit and when the claims were allowed, the specification described Figure 6 as:

a three frame x-ray showing ‘before and after’ views of a scoliosis patient who was treated in an investigational procedure using the system and method of the present invention.

'358 Patent (PX 1) at 4:38–41; '121 Patent (PX 2) at 4:44–47

? The original specifications also state the following: "[a]s shown in FIG. 6, investigative practice of the present method achieves efficacy never before seen in the orthopedic field." '358 Patent (PX 1) at 5:60– 62, '121 Patent (PX 2) at 6:10–13.

? In March 2015, during this litigation, Dr. Barry's law firm represented to Medtronic that "the x-rays depicted in Figure 6 were taken on or about July 10, 2003, and the surgery was performed June 10, 2003." DX 129; see

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